Comments Due by July 25 on EPA's Proposal Updating New Chemicals Regulations under TSCA

On May 26, 2023, the US Environmental Protection Agency (EPA or Agency) released a proposed rule¹ (the Proposal) to amend its regulations under the Toxic Substances Control Act (TSCA) applicable to new chemicals and significant new uses. EPA asserts the Proposal is intended to align the regulations with the new chemicals review provisions in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), enacted on June 22, 2016. Comments are due by July 25, 2023.

Key aspects of the Proposal include:

• Clarifying the information required to be submitted, to the extent known or reasonably ascertainable, for new chemicals notices in order for EPA to consider the notice complete.
• Updating the low volume exemptions (LVE) and low release and exposure exemptions (LoREX), including requiring EPA approval of an exemption notice prior to commencement of manufacture.
• Making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for LVE and LoREX exemptions and providing that certain persistent, bioaccumulative, toxic substances (PBT) are ineligible for these exemptions.

Some aspects of the Proposal closely follow the requirements of the Lautenberg Act. Others would expand EPA authority in ways not clearly contemplated in the statute and would implement policy decisions with potentially far-reaching consequences.

Proposed Changes for New Chemical Notices

Section 5(a)(1) of TSCA provides that no person may manufacture (including import) a new chemical substance or manufacture or process a chemical substance for a use which EPA has determined is a significant new use, unless at least 90 days prior to such manufacture or processing that person submits a notice to EPA containing the information required by TSCA section 5(d). Within the applicable review period, EPA must conduct a review of the notice, make one of five possible determinations regarding the likelihood of unreasonable risk of injury to health or the environment, and take any actions required as a result of that determination.

EPA is proposing to amend the regulations to specify that the Agency must make a determination on each premanufacture notice (PMN), significant new use notice (SNUN), and microbial commercial activity notice (MCAN) prior to the submitter commencing manufacturing or processing of the chemical substances, and to list the five possible determinations and actions associated with those determinations. Revisions would be made to 40 CFR 720.45 and the associated reporting form in the Central Data Exchange (CDX) to clarify the level of detail expected to be included for the submission. EPA states that "…a submitter would be required to include in the PMN form the detailed information proposed in this action, along with all other information already required, to the extent the information is known to or reasonably ascertainable by the submitter." Under 40 C.F.R. 720.30(p), the term "known to or reasonably ascertainable by" would be defined as "all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know." This definition goes beyond actual knowledge and on its face appears open to wide variability in interpretation.

Under 40 CFR 720.45, EPA is proposing to require that the following data be included for new chemicals actions:

• Physical and chemical properties of the substance that are found on the current PMN form fields will be added.
• Surface tension and ultraviolet–visible (UV–VIS) absorption, and any particle size distribution analysis, must be submitted, to the extent it is known to or reasonably ascertainable.
• Nanomaterials would require additional information on thickness, aspect ratio, and number of layers or walls.
• Environmental fate characteristics will be further detailed. Currently, this information is already collected by EPA as attachments to the PMN form but fields for environmental fate characteristics are not in CDX, so additional fields would be added to that system.
• Additional information regarding categories of use, such as estimated percentage of production volume per category of use, the percentage of the new substance in the formulation for each use (both commercial or consumer) and further details on commercial and consumer uses.
• Applicable consumer and commercial product categories using the Organization for Economic Co-operation and Development (OECD)-based functional use codes and TSCA section 8(a) Chemical Data Reporting.
• Site information where a substance is manufactured or processed to correspond with the PMN field form and details regarding the production process.
• Detailed information on possible worker exposure is being collected, including on protective equipment and engineering controls.
• Detailed information on potential environmental releases.

Notably, under the proposed amendments to 40 CFR 720.45(g)(3) and (4), and 720.45(h)(3) and (4), EPA is updating the language to ensure that submitters include worker exposure and environmental release information from exempt manufacture or related use of the chemical substances under 40 CFR 720.30 (e.g., a chemical substance manufactured under the byproduct or impurity exemptions or from FDA or pesticide program-regulated uses) at each site where the chemical substance will be manufactured, processed, or used, if known or reasonably ascertainable.

Furthermore, the Proposal asserts that the EPA will not consider a submission complete at the time of the initial submission if the submitter submits additional information at any time during the review period that was known to or reasonably ascertainable by the submitter at the time of initial submission. This provision puts potential notifiers in the position of excluding at their own peril any information it knows or "could have known" that EPA may later consider relevant.

Low Volume Exemptions and Low Release and Exposure Exemptions

EPA is proposing to amend the LVE and LoREX regulations at 40 CFR 723.50(g) to require a notification of approval of an LVE or LoREX from the Agency prior to commencement of manufacture of the chemical substance under the exemption.

Additionally, under 40 CFR 723.50, the Agency would be allowed to inform an LVE or LoREX holder whenever their chemical substance becomes subject to a proposed or final Significant New Use Rule (SNUR) that describes the chemical substance by a generic chemical name due to a confidentiality claim for its specific chemical identity. The Proposal also would notify certain LVE and LoREX holders that they might be subject to chemical data reporting.

Ineligibility of PFAS and Certain PBT Substances for Exemptions

The proposed amendments to the LVE and LoREX regulations would make PFAS categorically ineligible to be considered for these exemptions. EPA is proposing the same structural definition of PFAS as in the proposed rule, "Per- and Poly-fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule" (88 FR 4937, January 26, 2023).

EPA notes that, while the Agency has previously approved LVE notices for PFAS, in April 2021, EPA’s New Chemicals Program began implementing a new policy for reviewing and managing LVE notices for PFAS, under which EPA generally expects that pending and new LVE submissions for PFAS would be denied. EPA also notes that the Agency has never received or approved any PFAS LoREX notices.² EPA cites TSCA Section 26(c), 15 U.S.C. 2625(c), as supporting its categorical decision by rule on PFAS Notices. This section states, in relevant part:

Any action authorized or required to be taken by the Administrator under any provision of this chapter with respect to a chemical substance or mixture may be taken by the Administrator in accordance with that provision with respect to a category of chemical substances or mixtures. Whenever the Administrator takes action under a provision of this chapter with respect to a category of chemical substances or mixtures, any reference in this chapter to a chemical substance or mixture (insofar as it relates to such action) shall be deemed to be a reference to each chemical substance or mixture in such category.

With respect to PBT substances, EPA is proposing amendments to 40 CFR 723.50(d) that EPA asserts simply codifies its long-standing practice that, whenever EPA identifies a chemical substance under LVE or LoREX review as PBT with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms, that substance would not be eligible for LVE and LoREX status. EPA is proposing the following definition of a "PBT chemical substance": "a chemical substance possessing characteristics of persistence (P) in the environment, accumulation in biological organisms (bioaccumulation (B)), and toxicity (T) resulting in potential risks to humans and ecosystems."

The comment period ends July 25, 2023. EPA specifically asks for comments regarding the estimated burden of the Proposal and on the general pros and cons of clarifying these information requirements in the regulations and making corresponding changes to the PMN form. EPA also seeks comments on any information requirement details that are not clearly explained in the PMN form or the regulations.

Analysis

As noted above, EPA claims that the Proposal is intended to align its regulations with the amendments to the new chemicals review provisions contained in the Lautenberg Act, improve the efficiency of EPA's review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program. While some aspects of the Proposal closely follow the requirements of the Lautenberg Act, others would have the effect of expanding EPA authority in ways not clearly contemplated in the statute. Such changes could implement policy decisions that potentially have far-reaching consequences.

The Proposal aims to clarify the level of detail expected for the information a submitter is required to provide for PMNs, SNUNs, MCANs and exemption notices in order for EPA to consider the notice complete. Although it would be beneficial for industry and EPA to have a clear understanding regarding the notice requirements, it is important to understand that the Proposal would expand EPA authority in some areas. For example, EPA's current regulations at 40 CFR 723.50 regarding LVE and LoREX exemptions require the submission of a notice at least 30 days before manufacture and provide that EPA will review the notice and, upon expiration of the 30-day review period, a manufacturer may consider its exemption approved if EPA has taken no action. EPA is proposing to require a notification of approval of an LVE or LoREX from the Agency prior to commencement of manufacture of the chemical substance under the exemption. EPA’s explicit authority for such a requirement is unclear.

Additionally, under the Proposal, submitters must include worker exposure and environmental release information "if known or reasonably ascertainable." This is an area to watch with respect to how these requirements could get pulled into environmental justice initiatives³ at the Agency and potentially overlap with requirements of the Occupational Safety and Health Administration.

It is uncertain whether these amendments will actually achieve EPA’s stated goals of reducing the length of time that new chemical notices are under review and reducing frequency with which notices are amended with additional information and the amount of re-work of risk assessments that EPA conducts following such amendments. What is certain is that the Proposal would require submission of information well beyond what notifiers historically have been submitting, including information not known to the notifier, and also that EPA hopes to use its "incomplete application" authority to justify inaction within the statutory time periods and prevent applicants from obtaining judicial review of its decisions.

Furthermore, the Proposal would make PFAS categorically ineligible for LVE and LoREX exemptions and provide that certain PBT substances are ineligible for these exemptions. These changes may make it more difficult for certain chemicals to gain regulatory approval, which likely is the intent of the Agency. If so, this aspect of the Proposal would go well beyond the Lautenberg Act, and would seemingly be used to accomplish other policy goals of EPA.

Companies and other entities that could be affected by the Proposal should consider submitting comments by July 25, 2023 (as an extension seems unlikely).

Endnotes

¹Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA), 88 Fed. Reg. 34100 (May 26, 2023). Docket no. EPA-HQ-OPPT-2022-0902.

²See Press Release, EPA Announces Changes to Prevent Unsafe New PFAS from Entering the Market (Apr. 27, 2021), https://www.epa.gov/chemicals-under-tsca/epa-announces-changes-prevent-unsafe-new-pfas-entering-market

³ See, e.g., FACT SHEET: President Biden Signs Executive Order to Revitalize Our Nation’s Commitment to Environmental Justice for All, April 21, 2023. https://www.whitehouse.gov/briefing-room/statements-releases/2023/04/21/fact-sheet-president-biden-signs-executive-order-to-revitalize-our-nations-commitment-to-environmental-justice-for-all/